Biological indicators, and systems and methods for determining efficacy of sterilization

Abstract

A biological indicator includes: a BI housing; a germinant container inside the BI housing and housing a germinant composition; a germinant releaser configured to release the germinant composition from the germinant container; a germinant releaser support supporting the germinant releaser and configured to bring the germinant releaser into contact with the germinant container upon application of a force to the germinant releaser support or the germinant container; a first spore carrier inside the BI housing, the first spore carrier having a plurality of spores deposited at a first surface thereof; and an imaging window at a first surface of the BI housing. A BI reader is configured to detect and quantify the presence of live spores in the BI, and includes an excitation source, a camera for capturing images of the spores over time, and a processor for analyzing the images to determine the presence of live spores.

Description

BACKGROUND[0001]Several industries require sterilization of certain equipment before that equipment can be reused. One of the largest, and most recognizable, industries with such a requirement is the medical industry, which requires sterilization of various equipment—ranging from surgical instruments to routine medical devices to certain implants—to ensure safety for use. In general, sterilization procedures are designed to kill all viable living organisms within a sterilization chamber. However, sterilization can be challenging, as objects can be contaminated with numerous different types of bacteria, which carry varying levels of danger and difficulty to kill. As such, it is common (and in some industries required) to test the efficacy of each sterilization run to determine if the run successfully sterilized the equipment subjected to the run.[0002]To assess whether a sterilization run was successful (e.g., achieved adequately lethal conditions), sterilization indicators are typic...

AI Technical Summary

Benefits of technology

The present patent discloses devices, systems, and methods for quickly and accurately determining the effectiveness of a sterilization process. This is important for ensuring the safety and reliability of sterilized equipment. The technology allows multiple biological indicators to be tested simultaneously, making the process quicker and more efficient. The biological indicator also provides a direct reading of the presence of live spore(s) after sterilization. Overall, the technology improves sterility assurance results while saving time and resources.

Problems solved by technology

However, sterilization can be challenging, as objects can be contaminated with numerous different types of bacteria, which carry varying levels of danger and difficulty to kill.

Chemical indicators, however, only provide a rough proxy for sterilization success, and therefore may be unreliable.

Most of these assays rely on indirect measurement of microorganism survival, and do not quantify the microorganism survival.

However, the accuracy of such indirect measurements is susceptible to exogenous factors unrelated to the biological changes of interest, which renders these indirect methods less reliable.

Additionally, current sterility assurance technologies often rely on these nonquantitative measurements of microorganism survival, and simply return a positive result (indicating microorganism survival and therefore sterilization failure) or a negative result (indicating no detected microorganism survival and therefore sterilization success).

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